Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025
Efficacy and safety of Shuxuening injection in patients with unstable angina: a multicenter, randomized, placebo-controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Yu Lintong, Tao Shiyi, Lin Qian, Gao Sheng, Hu Xitian, Li Xiaoping, Wang Xiaofeng, Chen Huijun, Ji Xianyou, Lian Qiufang, Jin Daoqun, Xu Jingyu, Feng Jun, Qu Yanling, An Deying, Qi Chunmei, Chen Ling, Zheng Mingqi, Cao Guiqiu, Liu Jing, Gao Dongmei, Ma Mingfeng, Song Shujiang, Wang Yuesong, Zhao Lizhi, Zhu Zhongsheng, Zhang Yigang, Xiao Wei, Sun Yuanyuan, Zou Ting, Li Helin
Аннотация
OBJECTIVE: To determine the efficacy and safety of adjunct Shuxuening Injection (SXN) on conventional therapy in patients with unstable angina (UA) which provides a complementary choice and its evidence for clinical medication for treating UA.
METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial, 469 patients with UA from 25 hospitals in China who had an episode of angina within 48 hours were randomly assigned 3:1 to SXN and placebo group for 10 days in addition to conventional treatment. The primary outcome is the frequency of angina pectoris attacks after 10 days of intervention. The secondary outcomes are the frequency of angina pectoris attacks on day 30, the duration of angina pectoris symptoms, the visual analogue scale (VAS) score, total score of angina pectoris symptoms, the Global Registry of Acute Coronary Events (GRACE) score, total ischemia burden (TIB), and the level of high-sensitivity C-reactive protein (hs-CRP).
RESULTS: A total of 469 participants from 25 hospitals in China were enrolled in this trial. After 10 days of treatment, the frequency and duration of angina pectoris attacks, VAS score, and total score of angina pectoris symptoms exhibited a significant improvement in the SXN group compared to the placebo group both on days 10 and 30 (all p < 0.05). The GRACE risk score classification, TIB, and hs-CRP levels in the SXN group showed no statistically significant decrease compared to the control group on day 10 (all p > 0.05). The medication compliance, concomitant medication, and rates of adverse events were similar between the two groups (p > 0.05).
CONCLUSION: In patients with UA, SXN added on conventional treatment reduced the frequency and duration of angina pectoris attacks, even after discontinuation of the intervention for 20 days.
METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial, 469 patients with UA from 25 hospitals in China who had an episode of angina within 48 hours were randomly assigned 3:1 to SXN and placebo group for 10 days in addition to conventional treatment. The primary outcome is the frequency of angina pectoris attacks after 10 days of intervention. The secondary outcomes are the frequency of angina pectoris attacks on day 30, the duration of angina pectoris symptoms, the visual analogue scale (VAS) score, total score of angina pectoris symptoms, the Global Registry of Acute Coronary Events (GRACE) score, total ischemia burden (TIB), and the level of high-sensitivity C-reactive protein (hs-CRP).
RESULTS: A total of 469 participants from 25 hospitals in China were enrolled in this trial. After 10 days of treatment, the frequency and duration of angina pectoris attacks, VAS score, and total score of angina pectoris symptoms exhibited a significant improvement in the SXN group compared to the placebo group both on days 10 and 30 (all p < 0.05). The GRACE risk score classification, TIB, and hs-CRP levels in the SXN group showed no statistically significant decrease compared to the control group on day 10 (all p > 0.05). The medication compliance, concomitant medication, and rates of adverse events were similar between the two groups (p > 0.05).
CONCLUSION: In patients with UA, SXN added on conventional treatment reduced the frequency and duration of angina pectoris attacks, even after discontinuation of the intervention for 20 days.